WO2017006961A1 - Kit d'examen sanguin, et procédé d'analyse sanguine - Google Patents

Kit d'examen sanguin, et procédé d'analyse sanguine Download PDF

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Publication number
WO2017006961A1
WO2017006961A1 PCT/JP2016/070006 JP2016070006W WO2017006961A1 WO 2017006961 A1 WO2017006961 A1 WO 2017006961A1 JP 2016070006 W JP2016070006 W JP 2016070006W WO 2017006961 A1 WO2017006961 A1 WO 2017006961A1
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Prior art keywords
blood
plasma
test kit
diluted
concentration
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PCT/JP2016/070006
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English (en)
Japanese (ja)
Inventor
山下　清司
中津川　晴康
進 大澤
晋哉 杉本
Original Assignee
富士フイルム株式会社
株式会社リージャー
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Application filed by 富士フイルム株式会社, 株式会社リージャー filed Critical 富士フイルム株式会社
Priority to EP16821430.2A priority Critical patent/EP3321675A4/fr
Priority to CN201680039609.7A priority patent/CN108139380A/zh
Priority claimed from JP2016133962A external-priority patent/JP6518630B2/ja
Publication of WO2017006961A1 publication Critical patent/WO2017006961A1/fr
Priority to US15/861,353 priority patent/US10746723B2/en

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard

Definitions

  • the present invention relates to a blood test kit and a blood analysis method for performing a blood test by mailing a component of a trace amount of blood collected by a subject in a stable state.
  • a general qualified blood sample is collected by a doctor or other qualified person using a syringe to collect blood from the vein, and the subject is self-collected by inserting a blood collection needle into his / her finger or the like. There is blood sampling.
  • Blood collected by general blood collection is transported to a medical institution or inspection in a state of being sealed in a collection container, where it is inspected.
  • a test is performed after blood is separated into blood cells and plasma by a centrifuge at a medical institution or inspection institution.
  • the collected blood is separated into blood cells and plasma by a separation membrane and transported to the examination site in this separated state, where the examination is performed.
  • Patent Document 1 the amount of a component to be analyzed in a sample is measured, and further, the amount of a standard component originally present in the sample other than the above is measured.
  • a quantitative analysis method is described in which the amount of a sample is determined from the known concentrations of the standard components, and the concentration of the analysis target component in the sample is determined from the sample amount and the analysis target component amount.
  • Patent Document 2 describes a method for examining a blood sample collected by self blood collection. Specifically, 1) Prepare a sample for quantification consisting of an unknown volume of a biological sample containing a component to be quantified collected without quantifying the volume and a fixed amount of an aqueous solution containing a fixed amount of an indicator substance.
  • Patent Document 3 describes that a small amount of blood is collected from a human or animal using a blood dilution quantification instrument and is supplied as it is or after dilution to supply a constant amount to another device, container or reagent.
  • Patent Document 4 describes a method of quantifying the concentration of a component to be quantified in a biological sample using the absorbance of an indicator substance in an aqueous solution for dilution.
  • a test subject collects a blood sample
  • it is collected with a lancet equipped with a small knife and is used for quantifying the concentration of an arbitrary component in the blood.
  • a 100 ⁇ L blood sample is collected. There is a need to do.
  • JP 2001-330603 A JP 2003-161729 A JP 2009-128202 A JP 2009-109196 A
  • the method of analyzing blood by diluting it with a buffer solution is a biological component stored in a buffer solution with physiological conditions of pH 7.4 and excellent in stability during transportation, but controls the influence of external temperature during mailing In particular, in the summer mailing, because some of the sample components are affected by this, a decrease or increase in the measured value occurs, and it is difficult to perform a highly accurate test.
  • the self-collected trace blood is collected and delivered to a blood analysis center or the like by means of mail or the like, so that there has been a problem that a change in blood components during that time affects the accuracy and a correct test result cannot be obtained. If only the method for determining the dilution factor described in Patent Documents 1 and 2 is employed, it is difficult to perform a highly accurate inspection when transporting as described above.
  • the present invention is a blood test kit for diluting a trace amount of blood with a diluent, determining a dilution ratio, and analyzing a measurement target component in the blood, and controlling the influence of an external temperature during mailing to control the trace amount
  • An object to be solved is to provide a blood test kit capable of mailing components in blood in a stable state. Furthermore, this invention makes it the subject which should be solved to provide the accurate blood analysis method which prevented the influence by the temperature of a measured value using said blood test kit.
  • a diluted solution for diluting a blood sample As a result of intensive studies to solve the above problems, the present inventors have found that a diluted solution for diluting a blood sample, a separating means for recovering plasma components from the diluted blood sample, and a diluted blood sample It has been found that a blood test kit that can solve the above problems can be provided by including a cold insulation means for keeping the container cold in a blood test kit that includes a container for containing a plasma component recovered from the blood. Furthermore, the present inventors use the blood test kit described above to determine the dilution factor using a standard component that is constantly present in blood and / or a standard component (internal standard substance) in a diluent.
  • a diluent for diluting the blood sample Separation means for recovering plasma components from the diluted blood sample;
  • a container for containing plasma components recovered from a diluted blood sample A blood test kit, comprising: a cold insulation means for keeping the container cold.
  • the cold insulation means includes a cold insulation agent and a cold insulation bag.
  • the cold insulation means further includes an accommodating member having a thickness of 35 mm or less that can accommodate a container for accommodating the collected plasma component.
  • the blood test kit includes a member that records a temperature history.
  • the blood test kit is a blood test kit for analyzing the concentration of a target component in a blood sample using a standard component that is constantly present in blood, and the diluent does not contain a standard component.
  • the blood test kit according to (6), wherein the standard component is sodium ion or chloride ion.
  • the blood test kit according to (6) or (7), wherein the standard components are sodium ions or chloride ions and at least one standard component.
  • the blood test kit is a blood test kit for analyzing the concentration of a target component in a blood sample using a standard component that is constantly present in blood and verifying the analysis.
  • the diluent includes a standard component that does not exist in blood, and the blood test kit is a blood test kit for analyzing the concentration of a target component in a blood sample using the standard component that is not present in blood.
  • the blood test kit according to any one of (1) to (10).
  • plasma is collected from a blood sample, the collected plasma is diluted with a diluent, and the diluted plasma is diluted with blood.
  • plasma is collected from a blood sample, the collected plasma is diluted with a diluent, and the standard component that is present in the blood constantly in the diluted plasma Is used to determine the dilution ratio of plasma, analyze the concentration of the target component in the blood sample, and determine the dilution ratio of plasma using a standard component that is different from the above-mentioned standard component that is constantly present in blood.
  • a blood analysis method that verifies the analysis of the concentration of the target component.
  • plasma is collected from a blood sample, the collected plasma is diluted with a diluent, and the diluted plasma is used with standard components that are not present in the blood.
  • a blood analysis method for determining a dilution ratio of plasma and analyzing a concentration of a target component in a blood sample is Using the blood test kit according to (11), which includes a diluent that does not contain standard components that are constantly present in blood, plasma is collected from the blood sample, and the collected plasma is diluted with the diluent. In the diluted plasma, the standard component that is constantly present in the blood and the standard component that is not present in the blood are used to determine the dilution ratio of the plasma and analyze the concentration of the target component in the blood sample. Analysis method. (16) The blood analysis method according to any one of (12) to (15), wherein the amount of diluted plasma is 100 ⁇ L or more and 1000 ⁇ L or less.
  • components in a minute amount of blood can be mailed in a stable state, and highly accurate blood analysis can be performed while preventing the influence of the measured value on temperature.
  • the blood analysis method of the present invention it is possible to perform highly accurate blood analysis in which the influence of the measurement value due to temperature is prevented.
  • FIG. 1 shows an example of the configuration of a container for containing a plasma component collected from a diluted blood sample.
  • FIG. 2 is a schematic diagram of a moisture-proof case.
  • FIG. 3 shows the linearity of the sodium enzymatic assay.
  • a standard component that is constantly present in blood is called an external standard substance or external standard.
  • a standard component that does not exist in blood is called an internal standard substance or internal standard.
  • Patent Documents 1 and 2 describe a method for testing a blood sample separated by self blood collection.
  • Components that are constantly present in blood as standard components are sodium ions (Na +), chloride ions (Cl ⁇ ), potassium ions (K +), magnesium ions (Mg2 +), calcium ions (Ca2 +), total protein (TP ) And the like.
  • Na + sodium ions
  • chloride ions chloride ions
  • K + potassium ions
  • Mg2 + magnesium ions
  • Ca2 + calcium ions
  • TP total protein
  • TP total protein
  • sodium ion (Na +) or chloride ion (Cl ⁇ ) is preferable, and sodium is the highest amount in the blood among the components that are constantly present in the blood. Ion (Na +) is most preferred.
  • Patent Document 2 discloses a method for accurately determining the dilution rate of blood by containing an internal standard substance in a buffer solution when diluted with a buffer solution.
  • a standard component (external standard substance) and / or a standard component (internal standard substance) that are constantly present in blood and / or using a blood test kit including a cold insulation means for keeping the container cold.
  • the measurement value component can be analyzed by a blood analysis method that includes determining the dilution rate using () to reduce the variation in the measured value and enable highly accurate blood analysis.
  • a blood analysis method that includes determining the dilution rate using () to reduce the variation in the measured value and enable highly accurate blood analysis.
  • the measurement target component is affected by the influence of the external temperature during mailing. Even in a situation where an increase is likely to occur, the influence of the outside temperature during mailing can be easily controlled, and fluctuations in the measurement target component can be suppressed, and a highly accurate inspection can be performed.
  • the collection of micro blood using the blood test kit of the present invention is not limited in time and place, so it can be applied to cases that do not have time to go to medical institutions, disasters, telemedicine, health care, etc. Because it can be detected early, it can contribute to the reduction of medical costs.
  • a large amount of sample for example, 65 ⁇ L
  • a large amount of sample can be used for many tests such as 13 biochemical tests, tumor markers, and hepatitis tests.
  • the test data measured using the blood test kit of the present invention can be used in a system for daily health management and early detection of diseases by transmitting it to a smartphone.
  • the blood test kit of the present invention comprises a diluent for diluting a blood sample, a separating means for recovering plasma components from the diluted blood sample, and a blood sample collected from the diluted blood sample.
  • the blood test kit of the present invention is for diluting blood collected by a patient and transporting it to a medical institution or a test institution to analyze a component to be measured. There is a possibility of being left for a long time from blood collection to analysis. In the meantime, it is preferable to prevent decomposition and denaturation of the target component in the diluted blood.
  • the pH of blood is usually kept constant at about pH 7.30 to 7.40 in healthy individuals.
  • the diluent is preferably pH 6.5 to pH 8.0, more preferably pH 7.0 to pH 7.5, and still more preferably pH 7.3 to A buffer solution having a pH of 7.4 and containing a buffer component that suppresses fluctuations in pH is preferable.
  • the types of buffer include acetate buffer (Na), phosphate buffer (Na), citrate buffer (Na), borate buffer (Na), tartrate buffer (Na), Tris (Tris (hydroxy Methyl) aminoethane) buffer (Cl), HEPES ([2- [4- (2-hydroxyethyl) -1-piperazinyl] ethanesulfonic acid]) buffer, phosphate buffered saline (Na), etc. are known ing.
  • phosphate buffers, Tris buffers, and HEPES buffers are representative examples of buffers around pH 7.0 to pH 8.0.
  • the phosphate buffer contains a sodium salt of phosphate.
  • the Tris buffer Since the Tris buffer has a dissociated pKa (Ka is an acid dissociation constant) of 8.08, it is usually used in combination with hydrochloric acid in order to have a buffering ability in the vicinity of pH 7.0 to pH 8.0.
  • the pKa of HEPES sulfonic acid dissociation is 7.55, and a mixture of sodium hydroxide, sodium chloride and HEPES is usually used to prepare a buffer solution with a constant ionic strength.
  • these are useful as buffers having the action of keeping the pH constant, they contain sodium ions or chloride ions, which are preferably used as external standard substances in the present invention. It is not preferable. Therefore, the present inventors have intensively studied and found a new buffer solution that does not contain sodium ions or chloride ions.
  • the diluent containing no sodium ion and chloride ion that can be used in the present invention is preferably 2-amino-2-methyl-1-propanol (AMP), 2-ethylaminoethanol, N-methyl-D-glucamine. , Diethanolamine, and at least one amino alcohol compound selected from the group consisting of triethanolamine, and Good's buffer (Good buffer), which is also referred to as HEPES, which is a buffer having a pKa of around 7.4.
  • AMP 2-amino-2-methyl-1-propanol
  • 2-ethylaminoethanol N-methyl-D-glucamine
  • Diethanolamine and at least one amino alcohol compound selected from the group consisting of triethanolamine
  • Good buffer Good buffer
  • HEPES Good buffer having a pKa of around 7.4.
  • the concentration ratio of amino alcohol and Good's buffer solution is 1: 2 to 2: 1, preferably 1: 1.5 to 1.5: 1, more preferably 1: 1.
  • the concentration of the buffer is not limited, but the concentration of amino alcohol or Good's buffer is 0.1 to 1000 mmol / L, preferably 1 to 500 mmol / L, more preferably 10 to 100 mmol / L.
  • chelating agents In the buffer solution, chelating agents, surfactants, antibacterial agents, preservatives, coenzymes, saccharides and the like may be contained for the purpose of keeping the components to be analyzed stable.
  • chelating agents include ethylenediaminetetraacetate (EDTA), citrate, and oxalate.
  • surfactant include a cationic surfactant, an anionic surfactant, an amphoteric surfactant, and a nonionic surfactant.
  • the preservative include sodium azide and antibiotics.
  • coenzyme include pyridoxal phosphate, magnesium, zinc and the like.
  • saccharide of the erythrocyte stabilizer examples include mannitol, dextrose, oligosaccharide and the like.
  • by adding antibiotics it is possible to suppress the growth of bacteria partially mixed from the finger surface at the time of hand blood collection, to suppress the degradation of the biological components by bacteria, and to stabilize the biological components.
  • Components diluted with these buffers do not interfere with the measurement even with various measurement methods using biochemical / immuno-automated analyzers, and blood cells do not undergo hemolysis, and biological components can be stored as stably as possible even at 37 ° C. preferable.
  • the osmotic pressure of the buffer solution is equivalent to that of blood (285 mOsm / kg (mOsm / kg: 1 kg of solution water has It is possible to prevent hemolysis of blood cells by setting the osmotic pressure to the number of millimoles of ions)) or more.
  • the osmotic pressure can be adjusted to be isotonic with salts, sugars, buffers, etc. that do not affect the measurement of the target component and the measurement of the standard component that is constantly present in the blood.
  • a first example of a diluent for diluting a blood sample is a diluent that does not contain a substance that is constantly present in blood (hereinafter also referred to as a homeostatic substance) that is used when determining the dilution factor.
  • a homeostatic substance a substance that is constantly present in blood
  • does not contain means “does not contain substantially”.
  • substantially free means that the homeostatic substance used when determining the dilution factor is not included at all, or even if it is included, the homeostatic substance in the diluted solution after the blood sample is diluted It means the case where it is contained at a very small concentration that does not affect the measurement of the above.
  • sodium ions or chloride ions are used as the homeostatic substance
  • a diluent that does not substantially contain sodium ions or chloride ions is used as the diluent.
  • the blood test kit of the present invention is a blood test kit for analyzing the concentration of a target component in a blood sample using a standard component that is constantly present in blood, the diluent is the standard component. It is a diluted solution that does not contain.
  • a second example of a diluent for diluting a blood sample is a diluent containing an internal standard substance.
  • the internal standard substance can be added to a diluent used for diluting a biological sample so as to have a predetermined concentration.
  • a substance which is not contained in the blood sample at all or is contained in a trace amount even if it is contained can be used.
  • Internal standards include substances that do not interfere with the measurement of target components in blood samples, substances that do not degrade due to the action of biological enzymes in blood samples, substances that are stable in buffer solutions, and do not permeate the blood cell membrane. It is preferable to use a substance that is not contained in blood cells, a substance that is not adsorbed in a buffer storage container, or a substance that can use a detection system that can measure with high accuracy.
  • the internal standard substance a substance that is stable even if stored for a long time in a state of being added to a diluent that is a buffer solution is preferable.
  • examples of internal standard materials include glycerol triphosphate, Li, Rb, Cs, or Fr as alkali metals, and Sr, Ba, or Ra as alkaline earth metals, among which glycerol triphosphate Or Li is preferable.
  • These internal standard samples are colored by adding a second reagent at the time of concentration measurement after blood dilution, and the concentration in diluted blood can be determined from the color density.
  • the measurement of the internal standard substance of lithium added to the buffer solution uses a chelate colorimetric method (halogenated porphyrin chelate method: perfluoro-5,10,15,20-tetraphenyl-21H, 23H-porphyrin).
  • a biochemical automatic analyzer a lot of samples can be easily measured.
  • the blood test kit of the present invention is a blood test kit for analyzing the concentration of a target component in a blood sample using a standard component that is not present in blood, the diluent is present in the blood. This is a diluted solution containing standard components that do not.
  • a third example of a diluent for diluting a blood sample is a diluent that does not contain a standard component that is constantly present in the blood used when determining the dilution factor, and that contains an internal standard substance. .
  • Separation means for recovering plasma components from a diluted blood sample and a container for storing plasma components recovered from the diluted blood sample Separation for recovering plasma components from a diluted blood sample
  • an embodiment which is a separation membrane is preferable, and a filter having pores capable of separating blood cell components is more preferable.
  • the shape and size of the container for containing the plasma component collected from the diluted blood sample are not particularly limited.
  • the material of the container is preferably a synthetic resin from the viewpoint of resistance to breakage, hygiene, and price.
  • polyethylene polypropylene, polyvinyl chloride, polyvinylidene chloride, polystyrene, polyvinyl acetate, polyurethane, polyethylene terephthalate, polylactic acid, acrylonitrile butadiene styrene resin (ABS resin), acrylonitrile styrene resin (AS resin), acrylic resin (PMMA) , Polycarbonate, silicone resin, silicone rubber and the like.
  • ABS resin acrylonitrile butadiene styrene resin
  • AS resin acrylonitrile styrene resin
  • PMMA acrylic resin
  • Polycarbonate silicone resin, silicone rubber and the like.
  • a diluting solution for diluting a blood sample a first containing device containing the diluting solution, and a separation for separating and collecting plasma from the blood sample diluted with the diluting solution
  • a device a holding device for holding the separating device, a second containing device for containing the collected plasma, a sealing device for maintaining the contained plasma in the second containing device, and damaging the skin
  • It is equipped with a needle that bleeds blood outside the skin, a lancet, an adhesive bandage or disinfecting member (for example, a non-woven fabric impregnated with isopropanol (70% by mass isopropanol) or ethanol), an instruction manual, etc. be able to.
  • the first storage device and the second storage device may be used as a first storage device and a second storage device, or may be provided with separate devices.
  • the first storage device and the second storage device The instrument is preferably made of a transparent material.
  • transparent as used in the present invention is not limited as long as the observer can confirm the amount of liquid inside, and is a concept including translucency.
  • the holding device for holding the separation device is a gasket
  • the sealing device when the storage device is a tube-shaped device, a cap that can cover the opening, a cover having a spiral groove, or a rubber plug is used. can do.
  • a first storage device containing a diluent containing a blood sample diluted with the diluent
  • a holding device for holding the separation device for holding the separation device
  • a first device for containing the collected plasma are described, for example, in FIGS. 1 to 13 of Japanese Patent No. 3597827. Can be used.
  • FIG. 1 of Japanese Patent No. 3597827 is incorporated as FIG. 1 of the present application.
  • the blood separation instrument 1 includes a blood collection container 2 (first accommodation instrument in which a diluent is accommodated), a cylinder 3 (second accommodation instrument for accommodating the collected plasma) that can be inserted into the blood collection container 2, and
  • the cap piston 4 that can be attached to the cylindrical body 3 and a sealing lid 5 (sealing device) provided at the lower end of the cap piston 4, and before use, as shown in FIG.
  • the upper end opening is sealed with a cap 6 via a packing 7.
  • the container for storing the diluted blood sample in the present invention corresponds to the combination of the blood collection container 2 and the cylinder 3 in the configuration of FIG. That is, the container for storing the diluted blood sample may be one or a combination of two or more.
  • the blood collection container 2 is made of a transparent material and has a cylindrical shape.
  • a screw portion 8 is formed on the outer surface of the blood collection container 2 and an engaging portion 9 is projected on the inner surface.
  • an inverted conical bottom portion 10 is formed at the lower end portion of the blood collection container 2, and a cylindrical leg portion 11 is formed around the bottom portion 10.
  • the legs 11 have the same outer diameter as the sample cup used at the time of blood analysis and testing, and preferably, slit grooves 12 are formed in the vertical direction at positions opposite to the lower ends thereof. Further, as shown in FIG. 1, a required amount, for example, a diluted solution 13 of 500 mm 3 may be placed in the blood collection container 2 in advance.
  • the cylindrical body 3 is made of a transparent material and has a cylindrical shape, and an enlarged diameter portion 14 is formed at an upper end portion thereof.
  • the enlarged diameter portion 14 is connected to the main body portion 16 through a thin portion 15.
  • a reduced diameter portion 18 is formed at the lower end of the cylindrical body 3, and a locking projection 19 is formed on the inner surface of the reduced diameter portion 18.
  • the outer flange portion 20 (holding device) is formed at the lower end portion of the reduced diameter portion 18, the lower end opening portion of the outer flange portion 20 is covered with a filtration membrane 21 (separation device), and the filtration membrane 21 is in the blood. It allows passage of plasma and prevents passage of blood cells.
  • a silicon rubber cover 22 is attached to the outer periphery of the reduced diameter portion 18 (FIG. 1).
  • the cap piston 4 includes a substantially cylindrical knob 26 and a mandrel 27 that is concentric with the knob 26 and extends downward.
  • a cylindrical space 28 into which the enlarged diameter portion 14 of the cylindrical body 3 can be fitted is formed at the inner upper end portion of the knob portion 26, and the lower portion thereof is screwed and can be screwed into the screw.
  • the lower end portion 29 of the mandrel portion 27 is formed in a pin shape, and the sealing lid 5 is detachably provided on the lower end portion 29 (see FIG. 1).
  • the sealing lid 5 is made of silicon rubber.
  • Cooling means for keeping the container cold The preferred temperature at the time of mailing the blood sample is ⁇ 10 ° C. or more and 20 ° C. or less, and the particularly preferred temperature is 0 ° C. or more and 10 ° C. or less.
  • the above-described cold insulation can be achieved by including a cold insulation means in the blood test kit.
  • a cooling agent can be used as the cooling means.
  • the surface of the bag containing the cooling agent or the instructions may describe the cooling agent in advance in a freezer or the like, and the cooling time until the cooling agent can be cooled.
  • recovered plasma component and a cold insulating agent may be described.
  • the blood sampler can collect blood in consideration of the cooling time, and can store the blood sample in a predetermined cold insulation member.
  • the cryogen is not particularly limited.
  • examples of the aqueous solution of the inorganic salt include sodium chloride, ammonium chloride, and magnesium chloride.
  • the polyhydric alcohol include ethylene glycol and propylene glycol.
  • the gelling agent include carboxy.
  • hydrophilic polymers such as methylcellulose, polyvinyl alcohol, sodium polyacrylate, polyacrylamide, etc., with the addition of silver iodide, copper sulfide, xanthan gum, ⁇ -phenazine, sodium pyrophosphate as nucleating agents for freezing the cryogen , Etc.
  • the cryogens that are generally used in bags and used and marketed are about 99% water and highly water-absorbent resin (sodium polyacrylate), preservatives, and shape-stable. Since it contains an agent and has no cooling effect when it is thawed at room temperature, it should be first frozen in a freezer before use. The cryogen can be used over and over again after it has been warmed up or by freezing it.
  • Dilution with a buffer solution and subsequent separation and collection of plasma are important in reducing hemolysis of blood cells and elution effects of substances from blood cells.
  • cooling keeps the influence of substances in the buffer solution on blood components to a minimum, so that stabilization of the state after plasma separation is achieved in terms of maintaining the stability of the blood components of interest.
  • the purpose is to produce a synergistic effect on stabilization by designing an appropriate buffer (diluent).
  • Containers for storing specimens in the form of a solution obtained by diluting a minute amount of blood used for blood tests with a diluent, or containers for specimens in which plasma and blood cells are separated immediately after blood is collected and diluted can be cooled as described above. It is preferable to cover or surround with a state-of-the-art cryogen. Furthermore, it is preferable that the above container is placed in a cold insulation bag having a metal foil such as an aluminum film having a heat shielding property in order to extend the cold insulation time of the cold insulation agent, and the temperature caused by light absorption due to shielding of external light. It is preferable at the point which prevents a raise. That is, preferably, the cold insulation means includes a cold insulation agent and a cold insulation bag.
  • the structure has not only a cold insulation but also an impact mitigating effect by transportation.
  • the micro blood sampling kit of the present invention may be one factor that may be avoided.
  • the size is such that it can be inserted into the post entry port.
  • it is a post packet (size 340 mm ⁇ 250 mm ⁇ thickness 35 mm, weight 1 kg or less), it is not necessary to go to the post office, and it can be posted directly on the post. Moreover, it can be transported at a low cost, and there is a mail tracking service, which is preferable in terms of price and security.
  • a housing member that accommodates a container having a specimen having a thickness of 35 mm or less is included in the blood test kit as one of the cold insulation means, and the cold preservation agent is cooled in advance.
  • the cold preservation agent is cooled in advance.
  • a container for storing plasma components after separation of blood cells and plasma using a cryogen having a two-layer structure of a part where the cryogen is solidified by cooling and a part where the cryogen does not solidify is provided.
  • a thickness of 35 mm or less can be realized, and mailing can be performed easily and inexpensively.
  • a preferred embodiment of the blood test kit of the present invention is an embodiment having a member for recording a temperature history after use of the cold insulation means.
  • a member for recording the temperature history it is preferable to use a thermo label or an RFID (radio frequency identifier) tag.
  • a thermo label or an RFID (radio frequency identifier) tag By attaching a thermolabel or the like capable of detecting an appropriate temperature to the container having the sample, the maximum temperature before and after arrival at the analysis center can be checked, so that the status of the cold-retention effect during mailing can be grasped later.
  • an RFID tag equipped with a temperature sensor in the vicinity of a container that contains a blood sample, temperature changes during mailing can be managed in detail at the analysis center.
  • the bag containing the cooling agent can be washed and the surface is provided with an antibacterial coating or the like.
  • a preferred embodiment of the blood test kit of the present invention is an embodiment including an instruction describing how to use the cold insulation means.
  • a kit that includes a determination as to whether or not to use a cryogen during mailing is also a preferred embodiment.
  • the kit is described in the instruction to use a cold insulator. Is preferred.
  • the kit includes an irreversible thermolabel that can be used by removing the release paper, and by packaging the diluted blood and the irreversible thermolabel that has been used at the time of mailing, It becomes possible to grasp the maximum temperature at the time of mailing after blood collection.
  • the highest temperature that can be achieved after mail collection Is preferable because it is possible to appropriately grasp the above.
  • the number of each element included in the blood test kit of the present invention is not particularly limited, and may be one each or two or more.
  • the blood test kit of the present invention contains a diluent for diluting a blood sample, separation means for recovering plasma components from the diluted blood sample, and a plasma component recovered from the diluted blood sample Therefore, it is possible to provide a container for storing the cooling container and a cooling means for cooling the container in a storage container that stores them.
  • a blood sample can be collected using the blood test kit of the present invention, and the analysis target component in the blood sample can be measured.
  • the blood analysis method of the present invention may be carried out by self-collection in which the subject himself collects blood, or may be carried out in general blood collection in which a qualified person such as a doctor collects blood using a syringe. Good.
  • the biological sample to be analyzed is blood
  • blood is a concept including serum or plasma.
  • plasma or serum obtained by collecting a small amount of blood from a subject, diluting with a buffer solution, and then separating blood cells by a filter or centrifugation can be used.
  • the origin of the blood sample is not limited to humans, but may be animals other than humans (mammals, birds, fishes, etc.). Examples of animals other than humans include horses, cows, pigs, sheep, goats, dogs, cats, mice, bears, pandas, and the like. Preferably, the blood sample originates from a human.
  • the patient himself / herself collects the blood that has come out of the skin by damaging a fingertip or the like using an instrument with a knife such as a lancet.
  • the amount of blood collected from the patient used in the analysis method of the present invention is preferably 100 ⁇ L or less in consideration of the load on the patient.
  • the amount of diluted plasma after dilution with a diluent is preferably 100 ⁇ L or more and 1000 ⁇ L or less.
  • a component that is constantly contained in a blood sample is used as a standard component.
  • Specific examples include sodium ion (Na +), chloride ion (Cl ⁇ ), potassium ion (K +), magnesium ion (Mg2 +), calcium ion (Ca2 +), total protein (“TP”), albumin and the like.
  • the concentration of these standard components contained in the blood sample is such that the Na concentration is 134 to 146 mmol / liter (average value: 142 mmol / liter), the Cl concentration is 97 to 107 mmol / liter (average value: 102 mmol / liter), K concentration is 3.2 to 4.8 mmol / liter (average value: 4.0 mmol / liter), Mg concentration is 0.75 to 1.0 mmol / liter (average value: 0.9 mmol / liter), Ca concentration Is 4.2 to 5.1 mmol / liter (average value: 4.65 mmol / liter), the total protein concentration is 6.7 to 8.3 g / 100 mL (average value: 7.5 g / 100 mL), and the albumin concentration is 4.1 to 5.1 g / 100 mL (average value: 4.6 g / 100 mL).
  • a standard substance present in a high concentration in blood is highly resistant to the effects of contamination even if unintentional components other than blood are mixed in the diluted solution, and the test accuracy is high. It is considered that the decrease can be suppressed.
  • sodium ion or chloride ion is preferable, and among the standard components that are constantly present in blood, sodium ion having the highest amount present in blood is most preferable. Na ion accounts for 90% or more of the total cation in plasma at a standard value (normal value) of 142 mmol / liter.
  • plasma is collected from a blood sample using a blood test kit containing a diluent that does not contain standard components that are constantly present in blood, and the collected plasma is diluted. It is possible to analyze the concentration of the target component in the blood sample by diluting with a liquid, determining the dilution ratio of plasma using the standard component in the diluted plasma that is constantly present in the blood.
  • Sodium ion concentration and chloride ion concentration can be measured, for example, by flame photometry, atomic absorption, glass electrode, titration, ion selective electrode, enzyme activity, and the like.
  • a sample obtained by collecting a small amount of blood from a finger and diluting with a buffer solution is only about 150 ⁇ L, and more than 10 items of biochemical components and immunological test items are measured. It is preferable that it can be measured by. In addition, since it is necessary to analyze a large number of samples, it is preferable to be able to adapt to a commercially available biochemical / immunological automatic analyzer.
  • the preferred standard substance is sodium ion, the measured value (concentration X) of sodium ion in the diluted solution after blood dilution, and the known concentration value (concentration Y; concentration of sodium ion as the standard component in the blood sample). 142 mmol / liter), the dilution rate (Y / X) of the blood sample is calculated. By multiplying this dilution factor by the measured value (concentration Z) of the analysis target component in the diluted blood sample, the concentration [Z ⁇ (Y / X)] of the analysis target component actually contained in the blood sample is obtained. Is possible.
  • the dilution factor is independently determined for each of the two or more blood specimens containing different constitutively contained components as standard components. It is preferable to confirm that the values match.
  • the coincidence means that in two measured values (a, b), the ratio of their difference to their average value, that is,
  • the dilution rate is determined from the measured value of the sodium ion concentration in the blood plasma dilution of the blood sample and the known concentration value (142 mmol / liter) of sodium ion constantly contained in the plasma,
  • the dilution factor obtained from the standard component constantly contained in the plasma other than sodium ions is the dilution factor obtained from the sodium ion concentration.
  • a standard component that is constantly present in plasma other than sodium ion or chloride ion it is preferably selected from total protein or albumin, and more preferably selected from total protein.
  • Methods for measuring total protein include known methods such as the Burette method, the ultraviolet absorption method, the Breadford method, the Raleigh method, the bicinchoninic acid (BCA) method, and the fluorescence method.
  • a method to be used as appropriate can be selected according to the amount and the like.
  • the dilution concentration is determined using standard components that are not present in the blood.
  • a blood test kit containing a diluent containing a standard component that is not present in blood plasma is collected from the blood sample, the collected plasma is diluted with the diluent, and the diluted plasma is diluted with blood.
  • the dilution factor of plasma is determined using the standard component that is not present, and the concentration of the target component in the blood sample can be analyzed.
  • plasma is collected from a blood sample using a blood test kit containing a diluent containing standard components not present in blood, and the collected plasma is diluted with the diluent.
  • the above-mentioned standard component that is constantly present in the blood and the standard component that is not present in the blood are used to determine the dilution ratio of the plasma and analyze the concentration of the target component in the blood sample. be able to.
  • the dilution rate of the blood sample component is calculated by any one of the following formulas 1 to 4, and the concentration of the target component in the blood sample component is calculated by multiplying the concentration of the analysis target component in the diluted solution by the dilution rate. Is preferably analyzed.
  • A, B, C, D, B ′ and X are defined as follows.
  • X Multiplex of plasma dilution
  • the blood sample component is calculated by calculating with Equation 5 using the root-mean-square method, and multiplying the concentration of the analysis target component in the diluted solution by the dilution rate calculated with Equation 5.
  • An embodiment in which the concentration of the target component is analyzed is also preferable.
  • the present invention relates to a blood test kit for collecting blood by a patient, transporting the collected blood to a medical institution or testing institution, and performing a test, and a blood analysis method using the blood test kit. Therefore, there is a possibility of being left in a diluted state for a long time after blood collection until the test. If, for example, hemolysis of erythrocytes occurs during that time, substances or enzymes with high concentrations in the blood cells will become plasma or serum. If the sample is eluted and affects the test result, or the analysis target component is measured by color tone, hemoglobin may affect the test. Therefore, it is necessary to prevent hemolysis, blood coagulation, and the like during transportation. In the present invention, it is preferable to perform a step of separating blood cells from blood after diluting the blood collected by the patient with a diluent.
  • plasma separation after blood collection is preferably performed immediately after the blood is diluted with a buffer solution.
  • the blood is separated into blood cells and plasma components by centrifugation, and transported in a separated state, or the blood components are pressurized and passed through a separation membrane such as a filtration membrane.
  • a separation membrane such as a filtration membrane.
  • a method of separating a blood cell component from blood by capturing the blood cell component on a separation membrane is used.
  • backflow prevention described in JP-A-2003-270239 is preferred. It is preferable to use a biological sample separation instrument having means.
  • to analyze the concentration of a target component in a blood sample is to determine the concentration of the target component (that is, to quantify the target component), or whether the concentration of the target component is equal to or higher than a predetermined reference value.
  • concentration of the target component that is, to quantify the target component
  • concentration of the target component is equal to or higher than a predetermined reference value.
  • the form of analysis is not particularly limited, including determining whether it is below a predetermined reference value, performing qualitative detection that includes a certain level of concentration, and the like.
  • the analysis target component is not limited, and any substance contained in a biological sample is targeted. Examples include biochemical test items in blood used for clinical diagnosis, markers for various diseases such as tumor markers and hepatitis markers, and include proteins, sugars, lipids, low molecular weight compounds, and the like. Further, the measurement includes not only the substance concentration but also the activity of substances having an activity such as an enzyme. Each target component can be measured by a known method.
  • a method for efficiently analyzing a large number of samples with a commercially available biochemical / immunological autoanalyzer for quantitative determination of enzyme components of diluted plasma biological sample of unknown concentration in collected blood and enzyme activity It is.
  • This internal standard is preferably stable in a buffer solution for a long time and can be easily quantified. Specific examples include lithium and glycerol triphosphate.
  • sodium which is the external standard of the measurement sample, is stable because it is an element.
  • Sodium measurement is based on the fact that the enzyme activity of the enzyme galactosidase is activated by sodium ions, and it is possible to measure a sample of very low concentration sodium (24 mmol / L or less) diluted with a buffer solution in several ⁇ L. Simple enzymatic assays can be used.
  • This measurement method has a proportional relationship between the sodium concentration of the sample diluted with the buffer and the galactosidase activity, and can be applied to biochemical / immunological automatic analyzers, and does not require a separate measuring instrument for sodium measurement. It is a particularly preferable measurement method because it is highly efficient and economical.
  • Example 1 About 10 mL of blood collected with a syringe from a vein after informed consent from a volunteer patient was obtained in a blood collection tube. Prepare a sponge capable of absorbing about 65 ⁇ L of blood, and analyze GPT (glutamate pyruvate transaminase) and HbA1c (hemoglobin A1c) using DEMECAL (registered trademark) blood test kit (Regier Inc.) containing 300 ⁇ L of diluent. It went as follows. First, about 65 ⁇ L of blood is aspirated into the sponge using a blood collection device to which the sponge prepared as described above is attached using the above kit, and after elution into a diluted solution, plasma and blood cells are separated into a container.
  • GPT glutapyruvate transaminase
  • HbA1c hemoglobin A1c
  • thermolabel capable of detecting an environment of 40 ° C. was attached to the surface of the container.
  • a horizontally long housing member having a thickness of 30 mm, which has a space for a container containing a plasma / diluted plasma solution after separation of blood plasma and blood cells, and a space capable of storing a cryogen in an adjacent state on both sides of the container
  • the case was prepared, and a container containing a plasma / diluted plasma diluted solution was stored, and stored in a form sandwiched by a refrigeration agent (ice pack: registered trademark) cooled from both sides.
  • a thermolabel was affixed to the surface of the container containing the plasma dilution.
  • the case was sealed in a heat-insulating cold bag having an aluminum film that can be shielded from light, and the cold bag was packaged so that it could be mailed and stored in the same environmental conditions for 3 days.
  • thermo label of the container that does not use the cold storage means displayed a 40 ° C. history.
  • thermolabel of the container using the cold insulation means did not display a 40 ° C. history, and the actual temperature of the sample when using the cold insulation means was measured and found to be 3 ° C. to 9 ° C.
  • Method 1 Measure the sodium ion concentration in the diluted mixture, and calculate the dilution factor from this value and the concentration value for the sodium ion concentration of 142 mmol / L, which is normally evaluated as a component that is constantly present in the blood. It was.
  • Method 2 Using the glycerol monophosphate added in the diluent, the dilution ratio of plasma according to the method described in “Clinical Pathology Vol. 56, No. 7 (July 2008) Supplement 577-583” Asked.
  • Method 3 Using the value of the dilution factor obtained by the above method 1 and method 2, the dilution factor was determined according to the following method.
  • Method 3 Measurement of dilution ratio by combined use of external standard method and internal standard method
  • Examples of the external standard method using sodium ions are described below.
  • Table 1 shows measurement reagents for detecting sodium ions that do not contain sodium ions.
  • Table 2 shows the configuration of the internal standard addition diluent that does not contain sodium ions.
  • OSMOATAT OM-6040 manufactured by ARKRAY, Inc.
  • the dilution factor (X) was determined according to equation (1).
  • plasma and diluted plasma dilution ratio were obtained using JEOL Ltd. JCA-BM6050 type automatic analyzer.
  • X Plasma dilution rate
  • the concentration of the biochemical component in the diluted plasma is obtained by multiplying the measured value of the concentration of the reaction product using a known enzyme activity by the dilution factor determined by the above formula (1) to obtain the biochemical component in the original plasma.
  • Table 3 shows the maximum value, minimum value, and coefficient of variation CV (coefficient-of-variation:%) of the quantitative values of GPT and HbA1C obtained using the dilution ratios obtained in Method 1 to Method 3 above.
  • Example 2 After blood collection, when diluted with a buffer solution, plasma / blood cell separation was performed immediately after dilution using the plasma / blood cell separation device of DEMECAL blood test kit (Regier Co., Ltd.). Next, a case with a thickness of 30 mm that can be kept cold is prepared in the same way as in Example 1, and after being made cold so that it can be kept in the same way as in Example 1, it is packaged so that it can be mailed. Vibration was applied, and blood analysis was performed after 3 days at 25 ° C. The dilution factor was determined using Method 1 or Method 3 described in Example 1. As test items, GOT (glutamate oxaloacetate transaminase), HbA1C and CRE (creatinine) were measured.
  • GOT glutaxaloacetate transaminase
  • HbA1C and CRE creatinine
  • Plasma and blood cells are not separated immediately after blood dilution, but are stored in a similarly coolable case, and the same packaging is applied to provide transport vibration equivalent to 2500Km land transportation in Japan. Plasma and blood cells were separated by a separation method, and blood analysis was performed.
  • Table 4 shows the average value and coefficient of variation% of the quantitative results.
  • Example 3 An example of a method for determining the dilution rate of blood plasma will be described.
  • an internal standard addition dilution solution containing no sodium ion was prepared by changing glycerol triphosphate to 1 mmol / L of lithium chloride.
  • the internal standard substance of lithium added to the buffer was measured using chelate colorimetry (halogenated porphyrin chelate method: perfluoro-5,10,15,20-tetraphenyl-21H, 23H-porphyrin). It can be obtained by measuring.
  • the dilution rate of plasma with a buffer solution can be obtained by the following formula (2).
  • X (A + C) / (B + D) (2)
  • X Dilution ratio of plasma
  • a container containing a plasma / blood cell separated plasma-diluted solution is sandwiched with a cryogen.
  • Prepare a container containing plasma diluted solution with a thermolabel attached to the surface put it in a heat-insulating cold-insulated bag with an aluminum film that can be shielded from light, and make it possible to mail this cool-down bag
  • the product was packaged and stored in an environment of 25 ° C. to 40 ° C. under the same environmental conditions for 3 days.
  • Correlation coefficient (covariance of value (A) and value (B)) / ⁇ (standard deviation of value (A)) ⁇ (standard deviation of value (B)) ⁇ .... (3)
  • Example 4 In Example 1, the concentration of total protein was measured by the following method in addition to the measurement of sodium ion concentration, with respect to the plasma diluted solution stored in the container using the cold insulation means.
  • Diluted solution after blood dilution with respect to the dilution factor of the blood sample obtained from the measured value of sodium ion concentration in the plasma diluted solution and the average value 142 mmol / L of the concentration constantly contained in the blood sample The dilution factor obtained from the measured value of total protein in the blood sample and the average value of 7.5 g / 100 mL of the constant concentration of total protein, which is the standard component in the blood sample, is the same value. Results were obtained. Thereby, it turned out that the measurement using the dilution rate calculated
  • Example 5 As a return container for the DEMECAL blood test kit (Rieger Co., Ltd.), from the viewpoint of light shielding properties, heat shielding properties, and prevention of leakage of diluted plasma, an outer shape of 21.0 cm ⁇ 17.0 cm ⁇ 3. A 4 cm moisture-proof case (outside made of printable and printable paper) was prepared. A schematic diagram of the moisture-proof case is shown in the lower part of FIG. In the moisture-proof case 101, a package 102 of a DEMECAL kit and a case 103 with a return cooling agent are accommodated and returned.
  • the case 103 with the cooling agent for return (the upper part of FIG. 1) will be described below.
  • Inside the aluminum film 104 is a rectangular parallelepiped of outer dimensions 10.0 cm ⁇ 16.5 cm ⁇ 2.8 cm (the arrow in the figure indicates about 2.8 cm).
  • a non-solid cold-retaining agent 105 made of a water-soluble resin (sodium polyacrylate), an antiseptic, and a shape stabilizer is placed in a resin bag 106 having a moisture-proof cushioning property.
  • a space 107 for storing a 7 mm columnar bottle after plasma separation is provided. The bottle was stored in the space 107 so as to be sandwiched by a cold insulation agent, and a cold insulation pack that could be folded in two and stored in a moisture-proof case for return was produced.
  • RF radio frequency

Abstract

L'invention a pour objet de fournir : un kit d'examen sanguin avec lequel les effets de la température extérieure lors d'un envoi par la poste sont régulés, permettant ainsi l'envoi par la poste dans un état stable d'un composant contenu dans une très petite quantité de sang ; et un procédé d'analyse sanguine de haute précision qui met en œuvre ledit kit d'examen sanguin, et selon lequel le coefficient de variation d'une valeur mesurée est abaissé. Plus précisément, l'invention fournit un kit d'examen sanguin qui contient : une solution de dilution destinée à diluer un échantillon de sang ; un moyen de séparation qui est destiné à recueillir un composant plasma à partir de l'échantillon de sang ainsi dilué ; un réceptacle destiné à admettre le composant plasma recueilli à partir de l'échantillon de sang dilué ; et un moyen de maintien au froid destiné à maintenir au froid ledit réceptacle.
PCT/JP2016/070006 2015-07-06 2016-07-06 Kit d'examen sanguin, et procédé d'analyse sanguine WO2017006961A1 (fr)

Priority Applications (3)

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EP16821430.2A EP3321675A4 (fr) 2015-07-06 2016-07-06 Kit d'examen sanguin, et procédé d'analyse sanguine
CN201680039609.7A CN108139380A (zh) 2015-07-06 2016-07-06 血液检查试剂盒及血液分析方法
US15/861,353 US10746723B2 (en) 2015-07-06 2018-01-03 Blood test kit and blood analysis method

Applications Claiming Priority (4)

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JP2015-135068 2015-07-06
JP2015135068 2015-07-06
JP2016-133962 2016-07-06
JP2016133962A JP6518630B2 (ja) 2015-07-06 2016-07-06 血液検査キット及び血液分析方法

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JP2022024317A (ja) * 2020-07-15 2022-02-09 富士フイルム株式会社 管理システム及び管理方法
CN112014567B (zh) * 2020-08-20 2023-11-17 金华科生物技术河北有限公司 超敏c反应蛋白测定试剂盒

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JP2000258315A (ja) * 1999-03-12 2000-09-22 Arkray Inc 試料保持用具
JP2001330603A (ja) * 2000-05-18 2001-11-30 Arkray Inc 定量分析法
JP2003279564A (ja) * 2002-01-15 2003-10-02 Kyokuto Seiyaku Kogyo Kk 血液、血清又は血漿検体を安定化させる方法及びこれに使用する容器

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JP2000258315A (ja) * 1999-03-12 2000-09-22 Arkray Inc 試料保持用具
JP2001330603A (ja) * 2000-05-18 2001-11-30 Arkray Inc 定量分析法
JP2003279564A (ja) * 2002-01-15 2003-10-02 Kyokuto Seiyaku Kogyo Kk 血液、血清又は血漿検体を安定化させる方法及びこれに使用する容器

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MASATOSHI HORITA ET AL.: "Establishment of Mail Medical Examination System Using Immediate Plasma Separating Device by the Self-Collection Blood : The Method of Dilution Ratio Calculation by Using Internal Standard for the Sample with Different Amount of Collecting Blood", THE JAPANESE JOURNAL OF CLINICAL PATHOLOGY, vol. 56, no. 7, 25 July 2008 (2008-07-25), pages 577 - 583, XP009503400 *
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022024317A (ja) * 2020-07-15 2022-02-09 富士フイルム株式会社 管理システム及び管理方法
JP7378363B2 (ja) 2020-07-15 2023-11-13 富士フイルム株式会社 管理システム及び管理方法
US11953510B2 (en) 2020-07-15 2024-04-09 Fujifilm Corporation Management system and management method
CN112014567B (zh) * 2020-08-20 2023-11-17 金华科生物技术河北有限公司 超敏c反应蛋白测定试剂盒

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